Major Randomized Controlled Trials in Surgery.pptx

Major Randomized
Controlled Trials in
Surgery in the last 5
years
Dr. Pragya Singh
Postgraduate Resident
Department of General Surgery
PMCH, Udaipur

INTRODUCTION
In recent years,
investigators have
adapted RCT
methodology to the
field of surgery

INTRODUCTION
◉ RCTs remain the gold standard of evidence-based medicine
◉ Performance of high-quality RCTs within the field of surgery has historically
posed its own unique difficulties compared to medicine
 Standardization of clinical presentation
 Accounting for variations in operative
technique
 Ability to blind studies to reduce experimental
bias

Appendicitis
Long-term outcomes of antibiotics for
appendicitis were evaluated in a 5-year
follow-up paper of the APPAC
(Appendicitis Acuta) trial in Finland

Salminen P, Paajanen H, Rautio T, et al. Antibiotic Therapy vs Appendectomy
for Treatment of Uncomplicated Acute Appendicitis: The APPAC Randomized
Clinical Trial. JAMA. 2015;313(23):2340–2348
◉ Around 530 adults with CT-confirmed uncomplicated acute appendicitis
were randomized to either receive antibiotic therapy (n = 257) or
appendectomy (n = 273)
◉ About 70/256 patients who initially received antibiotics underwent
appendectomy within the 1st year and another 30/186 additional antibiotic-
treated patients underwent appendectomy between 1 and 5 years

Observations
◉ Of the 85 patients in the antibiotic group that underwent appendectomy,
only two had complicated appendicitis
◉ At 5 years, the complication rate was 24.4% in the appendectomy group
and 6.5% in antibiotic group (p<0.001)
◉ There was no difference between groups for length of hospital stay, but
there was a significant increase of 11 days in sick leave for the surgery
group

Conclusion
◉ Most appendectomies were open
◉ Complication rate and hospital stay may have been lower with the
laparoscopic approach
◉ Likelihood of recurrence decreases over time but over one-third of those
treated with antibiotics will have recurrent appendicitis within 5 years

Hernia
In recent years, RCTs have
focused on robotic-assisted
minimally invasive techniques
and the use of various mesh
types

Olavarria OA et al. Robotic versus laparoscopic ventral hernia repair:
multicenter, blinded randomized controlled trial. BMJ. 2020 Jul 14;370:m2457
◉ Adults with a ventral hernia defect < 12 cm were randomized to either
robotic ventral hernia repair (n = 65) versus laparoscopic ventral hernia
repair (n = 59)
◉ There was no difference in days in hospital within 90 days postsurgery
between the two groups nor in emergency department visits, wound
complications, hernia recurrence, or reoperation
◉ Robotic repair had a longer operative duration and increased healthcare
costs
◉ This study shows robotic ventral hernia repair confers no benefit but incurs
operating room time and cost

Kaufmann R et al. Mesh versus suture repair of umbilical hernia in adults: a
randomised, double-blind, controlled, multicentre trial. Lancet. 2018 Mar
3;391(10123):860-869.
◉ Around 300 adults with primary umbilical hernias of 1-4 cm were
randomized equally to either suture or mesh repair
◉ Primary outcome of hernia recurrence was significantly less in the mesh
than in the suture group
◉ Differences in other common postoperative complications were similar
◉ This RCT supports the use of mesh repair for small umbilical hernias

Jairam AP et al; PRIMA Trialist Group. Prevention of incisional hernia with
prophylactic onlay and sublay mesh reinforcement versus primary suture only in
midline laparotomies (PRIMA): 2-year follow-up of a multicentre, double-blind,
randomised controlled trial. Lancet. 2017 Aug 5;390(10094):567-576.
◉ About 480 adults undergoing an elective midline laparotomy for an
abdominal aortic aneurysm (AAA) repair or had a BMI>27 kg/m² were
randomized to closure with primary suture (n = 107); onlay mesh (n = 188),
or sublay mesh (n = 185) reinforcement
Incidence of wound infection
did not differ between groups
• Incisional hernia after 2 years was
significantly less in both mesh groups
• 33 (30%) with primary suture
• 25 (13%) with onlay mesh
reinforcement
• 34 (18%) with sublay mesh
reinforcement

Conclusion
◉ Onlay mesh reinforcement should be the standard treatment to prevent
incisional hernias for high-risk patients undergoing midline laparotomy
Critics of the conclusion argue
initial mesh use will make
subsequent hernia repairs
more complex

Reinforcement of Closure of Stoma Site (ROCSS) Collaborative and the
West Midlands Research Collaborative. Feasibility study from a randomized
controlled trial of standard closure of a stoma site vs biological mesh
reinforcement. Colorectal Dis. 2016 Sep;18(9):889-96.
◉ Total 790 patients were randomized to biological mesh or standard suture
closure
◉ After 2 years, incisional hernia was detected in 12% of patients in the mesh
group and 20% of controls
◉ Rates of wound infection, adverse events, and QOL were similar in both
groups
◉ Further follow-up at 5 years is awaited

Deerenberg EB et al. Small bites versus large bites for closure of abdominal
midline incisions (STITCH): a double-blind, multicenter, randomized controlled
trial. Lancet. 2015 Sep 26;386(10000):1254-1260.
◉ Total 560 adults underwent elective abdominal surgery with midline
laparotomy and were randomized to either small tissue bites of 5 mm every
5 mm with UPS 2-0 PDS (n = 276) or large bites of 1 cm every 1 cm with
thicker PDS 1-loop (n = 284)
◉ Primary outcome of incisional hernia at 1 year was significantly less in the
small bites group 35/268 (13%) versus 57/277 (21%) in the large bite group
◉ There was no significant difference in rates of adverse events such as ileus,
pneumonia, SSI, and burst abdomen

Löfgren J et al. A Randomized Trial of Low-Cost Mesh in Groin Hernia Repair.
N Engl J Med. 2016 Jan 14;374(2):146-53.
◉ Total 302 men with groin hernias operated electively by four surgeons were
randomized equally to either mosquito mesh
◉ There was no significant difference in neither the primary outcome of hernia
recurrence with 1 (0.7%) in the mosquito mesh and 0 in the commercial
group nor postoperative complications
◉ This RCT shows this low-cost mesh made of mosquito net is non-inferior to
commercial mesh for groin repair in men electively

BREAST SURGERY
◉ Intra-operative radiotherapy
◉ Anesthetic
◉ Pre-operative imaging
◉ Axilla
◉ Cavity shave margins
◉ Resection of the primary tumor in patients with metastatic breast cancer
◉ Breast reconstruction

Vaidya JS et al. Long term survival and local control outcomes from single dose
targeted intraoperative radiotherapy during lumpectomy (TARGIT-IORT) for early
breast cancer: TARGIT-A randomised clinical trial. BMJ. 2020 Aug
19;370:m2836.
◉ About 2,298 women with invasive ductal carcinoma up to 3.5 cm in size,
CN0-N1, were randomized to either targeted intraoperative radiotherapy
[TARGIT-IORT (n = 1,140)] or external beam radiotherapy [EBRT (n =
1,158)], which consisted of a standard daily fractionated course (3-6 weeks)
of whole breast radiotherapy
◉ TARGIT-IORT was supplemented by EBRT when postoperative
histopathology found unsuspected higher risk factors (20% of patients)

Observations
◉ In longer term follow-up, no statistically significant difference was found in
local recurrence-free survival, mastectomy-free survival, distant disease-
free survival, overall survival or breast cancer mortality
◉ TARGIT-IORT resulted in 14 fewer deaths compared with EBRT (42/1,140
vs. 56/1,158)
◉ Mortality from other causes was significantly lower with TARGIT-IORT

Conclusion
◉ TARGIT-IORT during lumpectomy is an effective alternative to EBRT, with
comparable long-term efficacy for cancer control and lower non-breast
cancer mortality
◉ Compared to EBRT, TARGIT-IORT is delivered to the tumor bed as a single
fraction during surgery and should therefore be discussed with all eligible
patients when breast-conserving surgery is planned

Sessler DI et al; Breast Cancer Recurrence Collaboration. Recurrence of
breast cancer after regional or general anesthesia: a randomized controlled trial.
Lancet. 2019 Nov 16;394(10211):1807-1815.
◉ Around 2,132 women undergoing curative breast cancer surgery were
randomized to either regional anesthesia or general anesthesia
◉ There was no difference in local recurrence among women regional
anesthesia-analgesia, 102 (10%) compared with 111 (10%) in the general
anesthesia group
 Trial was underpowered, slow to recruit, and did not
standardize the regional technique used
 Therefore, it is not a conclusive trial applicable and
generalizable to change practice but warrants further
study

Balleyguier C et al. Preoperative Breast Magnetic Resonance Imaging in
Women With Local Ductal Carcinoma in Situ to Optimize Surgical Outcomes:
Results From the Randomized Phase III Trial IRCIS. J Clin Oncol. 2019 Apr
10;37(11):885-892.
◉ About 358 women with DCIS undergoing breast-conserving surgery were
randomized to MRI group (n=178) or the control arm (n = 174)
◉ Addition of MRI did not reduce the rate of early reintervention
◉ Mastectomy rates were also similar
◉ MRI conferred no significant surgical improvement with the use of
preoperative MRI for DCIS staging

Kuemmel S et al. Prospective, Multicenter, Randomized Phase III Trial
Evaluating the Impact of Lymphoscintigraphy as Part of Sentinel Node Biopsy in
Early Breast Cancer: SenSzi (GBG80) Trial. J Clin Oncol. 2019 Jun
10;37(17):1490-1498.
◉ 1,198 patients with cN0 early breast cancer or extensive/high-grade DCIS
planned for standard radioactive-labelled colloid LSG with subsequent
SLNB were randomly assigned to know the results of the LSG or not
◉ Knowledge of the LSG did not increase the mean number of histologically
detected SLNs of 2.21 with LSG and 2.26 without LSG
◉ LSG does not improve SLNB surgery, negatively impacts the patient
pathway and increases cost

Giuliano AE et al. Effect of Axillary Dissection vs No Axillary Dissection on 10-
Year Overall Survival Among Women With Invasive Breast Cancer and Sentinel
Node Metastasis: The ACOSOG Z0011 (Alliance) Randomized Clinical Trial.
JAMA. 2017 Sep 12;318(10):918-926.
◉ This trial randomized women with clinical T1 or T2 invasive breast cancer,
no palpable axillary adenopathy, and 1 or 2 SLNs containing metastases to
either lumpectomy with SLND and ALND (n = 445) or just SLNB [SLND (n =
446)]
◉ At a median follow-up of 9.3 years, neither the 10-year overall survival nor
10-year disease-free survival was significantly different
◉ This study supports the use of conservative axillary management as an
alternative to ALND, for women with low burden axillary involvement,
tumors<5 cm, who undergo whole-breast radiation with systemic adjuvant
treatment

Chagpar AB et al. A Randomized, Controlled Trial of Cavity Shave Margins in
Breast Cancer. N Engl J Med. 2015 Aug 6;373(6):503-10.
◉ About 235 patients with stage 0-III breast cancer undergoing partial
mastectomy, with or without resection margins, were randomized equally to
have further cavity shave margins (shave) or no further shave (no-shave)
◉ Rate of positive margins after partial mastectomy (before randomization)
was not significantly different between the shave group and no-shave group
(36% and 34%, respectively; p = 0.69)

Observations and Conclusion
◉ After randomization, patients in the shave group had a significantly lower
rate of positive margins than those in the no-shave group, as well as a
lower rate of second surgery for margin clearance
◉ There was no significant difference in complications between the two
groups
◉ Cavity shaving halved the rate of positive margins and consequently
reduced the re-excision rate

Badwe R et al. Locoregional treatment versus no treatment of the primary
tumour in metastatic breast cancer: an open-label randomised controlled trial.
Lancet Oncol. 2015 Oct;16(13):1380-8
◉ About 350 women with previously untreated metastatic breast cancer were
randomized to receive chemotherapy and locoregional treatment directed at
their primary breast tumor and axillary lymph nodes (n = 173), or
chemotherapy and no locoregional treatment (n = 177)
◉ At time of cutoff, there were 235 deaths; 118 in the locoregional treatment
and 117 in the no locoregional group
◉ There was no significant different in the 2-year overall survival
◉ This study found no evidence for primary tumor treatment in metastatic
breast cancer

Negenborn VL et al. Quality of life and patient satisfaction after one-stage
implant-based breast reconstruction with an acellular dermal matrix versus two-
stage breast reconstruction (BRIOS): primary outcome of a randomised,
controlled trial. Lancet Oncol. 2018 Sep;19(9):1205-1214.
◉ Around 142 women about to undergo skin-sparing mastectomy with IBBR
were randomized to either one-stage IBBR with ADM (n = 69) or two-staged
approach (n = 73)
◉ One-stage group was associated with significantly higher risk of surgical
complications, reoperation, and removal of implant
◉ There was no significant difference in Breast-Q QOL domains, including
physical well-being, and sexual well-being, or in the patient-reported
satisfaction with breasts

UPPER
GASTROINTESTINAL
SURGERY

Werner YB et al. Endoscopic or Surgical Myotomy in Patients with Idiopathic
Achalasia. N Engl J Med. 2019 Dec 5;381(23):2219-2229.
◉ Total 221 patients were randomized to either POEM (n = 112) or LHM plus
Dor’s fundoplication (n = 109)
◉ At 2-year clinical success, defined as Eckardt symptom score of 3 or
less/12 without further treatment required, was achieved in 83.0% of
patients in the POEM group and 81.7% of patients in the LHM group
◉ Serious adverse events were significantly reduced in the POEM group
◉ However, POEM resulted in more reflux esophagitis at 3 months
◉ There was no difference in esophageal sphincter function nor in QOL index

Mariette C, et al; Fédération de Recherche en Chirurgie (FRENCH) and
French Eso-Gastric Tumors (FREGAT) Working Group. Hybrid Minimally
Invasive Esophagectomy for Esophageal Cancer. N Engl J Med. 2019 Jan
10;380(2):152-162.
◉ About 103 patients with resectable middle or lower thirds esophageal
cancer were randomized to either the hybrid-procedure group (n = 103), or
to the standard open-procedure group (n = 104)
◉ Hybrid surgery comprised of a two-field abdominal-thoracic operation with
laparoscopic gastric mobilization and open right thoracotomy
◉ Hybrid surgery reduced the rate of major postoperative complications from
64% in the open group to 36%, and improved overall and disease-free 3-
year survival from 55 to 67%, 48 to 57%, respectively

Korean Laparoendoscopic Gastrointestinal Surgery Study (KLASS) Group.
Effect of Laparoscopic Distal Gastrectomy vs Open Distal Gastrectomy on Long-
term Survival Among Patients With Stage I Gastric Cancer: The KLASS-01
Randomized Clinical Trial. JAMA Oncol. 2019 Apr 1;5(4):506-513.
◉ Total 1,416 patients were randomized to laparoscopic distal gastrectomy (n
= 705) or open distal gastrectomy (n = 711)
◉ 5-year overall survival rates were 94.2% in the laparoscopic group and
93.3% in the open surgery group (p = 0.64)
◉ Disease-free survival was also similar

REGATTA study investigators. Gastrectomy plus chemotherapy versus
chemotherapy alone for advanced gastric cancer with a single non-curable factor
(REGATTA): a phase 3, randomised controlled trial. Lancet Oncol. 2016
Mar;17(3):309-318.
◉ Total 175 patients with advanced gastric cancer with a single non-curable
factor confined to either the liver (H1), peritoneum (P1), or para-aortic lymph
nodes (16a1/b2) were randomly assigned to chemotherapy alone (n = 86)
or gastrectomy followed by chemotherapy(n = 89)
◉ Chemotherapy consisted of oral S-180 mg/m2/day on days 1-21 and
cisplatin 60 mg/m2 on day 8 of every 5-week cycle and gastrectomy was
restricted to D1 lymphadenectomy without any resection of metastatic
lesions

◉ At 2 years, overall survival was 31.7% for patients assigned to
chemotherapy alone compared with 25.1% for those assigned to
gastrectomy plus chemotherapy and median survival time was 16.6 months
and 14.3 months, respectively
◉ Study was halted due to futility as the predictive probability of overall
survival being significantly higher in the gastrectomy plus chemotherapy
group became 13.2%

Robert M et al. Efficacy and safety of one anastomosis gastric bypass versus
Roux-en-Y gastric bypass for obesity (YOMEGA): a multicenter, randomized,
open-label, non-inferiority trial. Lancet. 2019 Mar 30;393(10178):1299-1309.
◉ Around 261 patients with BMI>40 kg/m2 or >35kg/m2 and at least one
comorbidity (T2DM, hypertension, OSA, dyslipidemia, or arthritis) and with
no GERD were randomly assigned to OAGB (n=129) or RYGB (n = 124)
◉ After 2 years, the mean percentage excess BMI loss was 87.9% in the
OAGB group and 85.8% in the RYGB group, confirming non-inferiority
◉ Although OAGB was found to be noninferior to RYGB regarding weight loss
and metabolic improvement at 2 years it resulted in higher incidences of
diarrhea, steatorrhea, and nutritional adverse events

Stenberg E et al. Closure of mesenteric defects in laparoscopic gastric bypass:
a multicenter, randomized, parallel, open-label trial. Lancet. 2016 Apr
2;387(10026):1397-1404.
◉ Total 2,507 patients planned for laparoscopic gastric bypass surgery were
randomized closure of the mesenteric defects beneath the
jejunojejunostomy and at Petersen's space (n=1,259) or non-closure
(n=1,248)
◉ At 3 years, reoperation within 3 years for small bowel obstruction was more
common in patients who did not have mesenteric closure
◉ However, the closure of mesenteric defects increased the risk of severe
post-operative complications which may be due to kinking of jejunostomy

LOWER
GASTROINTESTINAL
SURGERY

Koskenvuo L et al. Mechanical and oral antibiotic bowel preparation versus no
bowel preparation for elective colectomy (MOBILE): a multicentre, randomised,
parallel, single-blinded trial. Lancet. 2019 Sep 7;394(10201):840-848.
◉ About 396 participants were randomized to MOABP (2 L of polyethylene
glycol, 1 L of clear fluid before 6 PM on the day before surgery, 2 g of
neomycin at 7 PM, and 2 g of metronidazole at 11 pm the day before
surgery) (n = 196), or no bowel preparation (NBP)(n = 200)
◉ Primary outcome of SSI within 30 days was detected in 13 (7%) patients
randomized to MOABP, and 21 (11%) to NBP
◉ Study was powered to detect an 8% difference in SSI rates but only
detected 4% and was, therefore, underpowered

Fleshman J et al. Effect of Laparoscopic-Assisted Resection vs Open Resection
of Stage II or III Rectal Cancer on Pathologic Outcomes: The ACOSOG Z6051
Randomized Clinical Trial. JAMA. 2015 Oct 6;314(13):1346-55.
◉ This trial randomized 486 patients with stage 2 or 3 rectal cancer within 12
cm of the anal verge after completion of neoadjuvant therapy to
laparoscopic (n = 240) or open resection (n=222)
◉ Primary outcome was a composite of circumferential radial margin>1 mm,
distal margin without tumor, and completeness of total mesorectal excision
◉ Successful resection occurred in 81.7% of laparoscopic resection cases
and 86.9% of open resection cases
◉ Laparoscopic resection failed to meet the noninferiority margin of 6%

◉ Conversion to open resection occurred in 11.3% of patients and the
operative time was significantly longer for laparoscopic resection (266.2 vs.
220.6 min; p <0.001)
◉ There was no significant difference in length of stay, readmission or severe
complications between the groups

ALaCaRT Investigators. Effect of Laparoscopic-Assisted Resection vs Open
Resection on Pathological Outcomes in Rectal Cancer: The ALaCaRT
Randomized Clinical Trial. JAMA. 2015 Oct 6;314(13):1356-63.
◉ This trial randomized 475 patients with T1-T3 rectal cancers across multiple
sites in Australia and New Zealand to open laparotomy and rectal resection
(n = 237) or laparoscopic rectal resection (n = 238)
◉ Successful resection was achieved in 194 patients (82%) in the
laparoscopic surgery group and 208 patients (89%) in the open surgery
group which failed to meet their margin of 8% for non-inferiority
◉ In laparoscopic surgery, the circumferential resection margin clear in 4%
fewer patient (93% vs. 97%), 5% less for total mesorectal excision (87% vs.
92%) but equivocal at 99% for distal margin clearance

Jayne D et al. Effect of Robotic-Assisted vs Conventional Laparoscopic Surgery
on Risk of Conversion to Open Laparotomy Among Patients Undergoing
Resection for Rectal Cancer: The ROLARR Randomized Clinical Trial. JAMA.
2017 Oct 24;318(16):1569-1580.
◉ About 471 patients with rectal adenocarcinoma suitable for curative
resection were randomized to robotic-assisted (n = 237) or conventional (n
= 234) laparoscopic rectal cancer resection
◉ There was no significant difference between the two in positive cancer
resection margins (CRM+)-14/244 (6.3%) in the conventional group and
12/235(5.1%) in the robotic-assisted group
◉ These CRM+ rates are significantly lower than in the other trials, suggesting
patient selection and surgeon experience for minimally invasive techniques
is key

Rullier E et al. Organ preservation with chemoradiotherapy plus local excision
for rectal cancer: 5-year results of the GRECCAR 2 randomized trial. Lancet
Gastroenterol Hepatol. 2020 May;5(5):465-474.
◉ This trial randomized 145 patients to either local excision (n = 74) or total
mesorectal (n=71) excision
◉ In the local excision, a completion was undertaken if tumor stage was ypT2-
3
◉ Trial failed to show superiority of local excision because 26/74 patients in
that group went on to have completion total mesorectal excision

Conclusion
◉ Composite outcome that included death, recurrence, and morbidity at 2
years was similar in both groups
◉ More research is needed to identify which patients will benefit from local
excision and can avoid unnecessary completion total mesorectal excision
◉ Currently, no benefit has been shown for postchemotherapy rectal cancer
organ preservation

The HubBLe Trial: haemorrhoidal artery ligation (HAL) versus rubber band
ligation (RBL) for symptomatic second- and third-degree haemorrhoids: a
multicentre randomised controlled trial and health-economic evaluation. Health
Technol Assess. 2016 Nov;20(88):1-150.
◉ About 337 participants were randomized to either HAL(n=161) or RBL (n =
176)
◉ For the primary outcome at 1-year postprocedure, 87/176 (49%) in the RBL
group and 48/161 (30%) in the HAL group had hemorrhoid recurrence and
more patients who had banding required a further procedure (14% vs. 32%)
◉ However, HAL was more painful postoperatively (p = 0.0002) and resulted
in more frequent serious adverse events (7% vs. 1%)

SCANDIV Study Group. One-year results of the SCANDIV randomized clinical
trial of laparoscopic lavage versus primary resection for acute perforated
diverticulitis. Br J Surg. 2017 Sep;104(10):1382-1392.
◉ About 199 participants with perforated colonic diverticulitis were
randomised to laparoscopic lavage (n = 101) or primary resection (n = 98)
◉ All patients with fecal peritonitis underwent colon resection
◉ Mortality at 90 days and major complications (30.7% vs. 26%, respectively)
were similar in both groups
Length of operation was significantly shorter in the lavage
group but this did not translate to a difference in length of
stay in hospital potentially due to the increased rate of
reoperations in the lavage group than in the colon resection
group

HEPATO-
PANCREATO-BILIARY
SURGERY

Dutch Pancreatitis Study Group. Effect of Early Surgery vs Endoscopy-First
Approach on Pain in Patients With Chronic Pancreatitis: The ESCAPE
Randomized Clinical Trial. JAMA. 2020 Jan 21;323(3):237-247.
◉ About 88 patients with painful chronic pancreatitis were randomized equally
to pancreatic drainage surgery or the endoscopy-first approach group, who
underwent medical treatment, endoscopy including lithotripsy if needed, and
surgery if needed
◉ In the 18-month follow-up period, patients in the early surgery group had a
lower pain score than patients in endoscopy-first group
◉ Early surgery group also required fewer overall number of interventions
◉ Treatment complications, mortality, hospital admissions, pancreatic
function, and QOL were not significantly different between the interventions

ChroPac Trial Group. Partial pancreatoduodenectomy versus duodenum-
preserving pancreatic head resection in chronic pancreatitis: the multicentre,
randomised, controlled, double-blind ChroPac trial. Lancet. 2017 Sep
9;390(10099):1027-1037.
◉ 226 patients were analyzed in the DPPHR (n=115) or partial
pancreatoduodenectomy (n=111) groups
◉ There were no differences in major adverse events (64% in the DPPHR and
52% after partialpancreatectomy), or QOL after 2 years
◉ This differs from other recent single-centre trials showing superiority of
DPPHR

Dutch Pancreatitis Study Group. Endoscopic or surgical step-up approach for
infected necrotising pancreatitis: a multicentre randomised trial. Lancet. 2018 Jan
6;391(10115):51-58.
◉ About 98 patients were equally assigned to each group
◉ Rates of death or major complication within 6 months: 43% in the
endoscopy group versus 45% in the surgery group and mortality rates were
similar between the groups
◉ In patients with infected necrotizing pancreatitis, the endoscopic step-up
approach was not inferior to the surgical step-up approach in reducing
major complications or death

Dutch Pancreatitis Study Group. Same-admission versus interval
cholecystectomy for mild gallstone pancreatitis (PONCHO): a multicentre
randomised controlled trial. Lancet. 2015 Sep 26;386(10000):1261-1268.
◉ At 23 hospitals in the Netherlands, 266 inpatients were randomly assigned
to interval cholecystectomy (n = 137) or same-admission cholecystectomy
(n = 129)
◉ Primary endpoint was a composite of readmission for recurrent gallstone-
related complications or mortality within 6 months after randomization
◉ This occurred in 23 (17%) patients in the interval group and in 6 (5%) in the
same-admission group
◉ This trial showed in patients mild biliary pancreatitis, same admission
cholecystectomy safely reduces the risk of recurrent pancreatitis and other
gallstone-related sequelae

Loozen CS et al. Laparoscopic cholecystectomy versus percutaneous catheter
drainage for acute cholecystitis in high risk patients (CHOCOLATE): multicenter
randomized clinical trial. BMJ. 2018 Oct 8;363:k3965.
◉ About 142 patients at high risk, as per an APACHE II score >7, were
randomized to laparoscopic cholecystectomy (n = 66) or to percutaneous
catheter drainage (n = 68)
◉ Trial was concluded early after a planned interim analysis because although
the rate of death did not differ between the laparoscopic cholecystectomy
and percutaneous catheter drainage groups (3% vs. 9%, p = 0.27), there
were significantly more major complications in the percutaneous drainage
group

van Beekum CJ et al. Normothermic Machine Perfusion (NMP) of the Liver -
Current Status and Future Perspectives. Ann Transplant. 2021 Aug
24;26:e931664.
◉ About 270 harvested livers were randomized to normothermic
perfusion(n=137) or standard cold storage (n = 133)
◉ This normothermic machine perfusion resulted in a 50% lower level of graft
injury compared to standard cooling, a 50% lower rate of organ discard
(11.7% vs. 24.1%, p = 0.008) and 54% longer mean preservation time (11 h
54 min vs.7h 45 min, p <0.001)
◉ There was no significant difference in bile duct complications, graft survival
or survival of the recipient

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