Clinical trial NCT05463328: Open Versus Laparoscopic Assisted Pancreaticoduodenectomy
Official title: Open Versus Laparoscopic Assisted Pancreaticoduodenectomy: Randomized Control Comparative Prospective Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pancreas Neoplasm
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2022-07-19
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Compare open and laparoscopic assisted pancreaticoduodenectomy regarding intraoprative blood loss, organ injury, completion of planned laparoscopic steps, duration and early post operative course of pain, hem stability, oral feeding, leakage(pancreatic, billary and intestinal). ,bleeding, mortality, lymph nodes and safety margins .

Detailed description: Pancreaticoduodenectomy is the only option curative intended in the treatment of resectable pancreatic ductal adenocarcinomas, duodenal carcinoma, ampullary carcinoma, lower common bile duct cholangiocarcinoma,. It is still associated with very high morbidity and mortality. \[1\]. Pancreatic cancer ranks as the seventh leading cause of cancer-related death worldwide, and the fourth among other cancers\[2,3\]. In recent years, the minimally invasive techniques has considered revolution in surgeries of pancreatic cancers \[4,5\]. Laparoscopic assisted pancreaticoduodenectomy is a hybrid procedure combining laparoscopic resection and reconstruction through a small incision.it companies laparoscopic mobilization and dissection due to magnification compared with open pancreaticoduodenectomy\[6\]. Several studies have shown that laparoscopic assisted pancreaticoduodenectomy could result in less blood loss less, pain ,less wound infection and shorter hospital stay compared to open pancreaticoduodenectomy\[7,8\]. Limited literature described the safety and efficacy of laparoscopic assisted pancraticododenostomy .Also such comparative studies deficient in evaluation of outcomes of laparoscopic assisted pancraticododenostomy and open pancraticoduodenoctomy.So the interest of our study is to compare between the feasibility and safety of laparoscopic assisted pancraticododenostomy and open pancraticoduodenoctomy.

Eligibility criteria: Inclusion Criteria:

1. age less than 70 years.
2. resectable tumour,
3. fit for surgery

Exclusion Criteria:

1. patients with jaundice with serum bilirubin above 200mml/dl.
2. patients with bleeding tendency until corrected.
3. patients with advanced and metastatic malignancy.
4. patients with cardiopulmonary diseases.

Primary outcomes:
measure: post operative pain.
timeFrame: Compare the post operative pain between open and laparoscopic assisted pancreaticoduodenctomy in the first week after operation
measure: Blood loss
timeFrame: Compare the intra operative blood loss between open and laparoscopic assisted pancreaticoduodenectomy during the operation
measure: Rate of postoperative anastomosis leakage(pancreatic,billary and intestinal).
timeFrame: Rate of postoperative anastomosis leakage(pancreatic,billary and intestinal) in the first month after operation
Secondary outcomes:
measure: Postoperative haemorrhage
timeFrame: In the first 2 weeks
measure: Postoperative wound infection.
timeFrame: In the first 2 weeks
measure: Starting oral feeding
timeFrame: In the first 3 days after operation
measure: Postoperative 30 days mortality rate.
timeFrame: In the first 30days after operation
Other outcomes:
Locations:
Study officials:
References:
citation: Newhook TE, LaPar DJ, Lindberg JM, Bauer TW, Adams RB, Zaydfudim VM. Morbidity and mortality of pancreaticoduodenectomy for benign and premalignant pancreatic neoplasms. J Gastrointest Surg. 2015 Jun;19(6):1072-7. doi: 10.1007/s11605-015-2799-y. Epub 2015 Mar 24.
citation: Erratum to "Cancer statistics, 2021". CA Cancer J Clin. 2021 Jul;71(4):359. doi: 10.3322/caac.21669. Epub 2021 Apr 19. No abstract available.
citation: Correction to Lancet Gastroenterol Hepatol 2019; 4: 934-47. Lancet Gastroenterol Hepatol. 2020 Mar;5(3):e2. doi: 10.1016/S2468-1253(20)30018-2. No abstract available.
citation: Bausch D, Keck T. Minimally Invasive Surgery of Pancreatic Cancer: Feasibility and Rationale. Visc Med. 2018 Dec;34(6):440-443. doi: 10.1159/000495324. Epub 2018 Nov 28.