Clinical trial NCT05171361: Pancreaticogastrostomy Versus Pancreaticojejunostomy With Dunking Technique After Pancreaticodudenectomy: A Prospective Randomized Comparative Study
Official title: Pancreaticogastrostomy Versus Pancreaticojejunostomy With Dunking Technique After Pancreaticodudenectomy: A Prospective Randomized Comparative Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pancreaticobiliary Cancer
Keywords: pancreaticojejunostomy
pancreaticogastrostomy
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2021-12-28
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All cases of resectable periampullary carcinomas

Brief summary: To compare between the outcomes of pancreaticogastrostomy and pancreaticojejunostomy with dunking technique after Pancreaticodudenectomy in the treatment of operable periampullary malignancies.

Detailed description: Pancreaticoduodenectomy remains the treatment of choice for periampullary malignancies. Advances in pancreatic surgery techniques and perioperative care have led to reduced mortality rates for Pancreaticodudenectomy \[1\]. However, morbidity after pancreatic resection remains high, with 30-60% of patients experiencing complications following surgery, mainly as a result of leak and subsequent fistula from the pancreatic anastomosis \[2\].The leakage of the pancreatic anastomosis remains the most serious problem as it is the major cause of morbidity after pancreaticoduodenectomy, and also contributes significantly to prolonged hospitalization \[5\]. For this reason, surgeons have always directed their efforts at reducing the rate of pancreatic fistula through the introduction of new and effective methods of construction of the pancreatic anastomosis \[6\]. Various techniques have been described for joining the pancreatic stump either with the jejunum or with the stomach, with or without internal or external drainage of the pancreatic duct. Recently, new prospective randomized studies have demonstrated the advantage of pancreaticogastrostomy over pancreaticojejunostomy in reducing the incidence of pancreatic fistula \[3\]; however, none of these techniques has proved to be superior in minimizing postoperative mortality and morbidity \[4\]. One of the difficulties of pancreatic reconstruction after pancreaticoduodenectomy is the presence of soft pancreas which leads to high risk of fistula so dunking technique was raised \[8\]. But few researches or papers have focused on its efficacy and even fewer papers have discussed dunking in pancreaticogastrostomy and pancreaticojejunostomy, So this is the interest of our study to compare between the efficacies of these two techniques.

Eligibility criteria: Inclusion Criteria:

* All cases of resectable periampullary carcinomas (cancer head of pancreas, ampullary carcinoma, distal cholangiocarcinoma and second part of duodenum adenocarcinoma) that are surgically fit according to ASA.

Exclusion Criteria:

* 1. Surgically unfit cases according to ASA 2. Locally advanced irresectable cases
* Abutment or encasement of coeliac trunk
* Encasement of SMA less than 180 degree of its axis
* Encasement of portal/SMV more than 180 degree of its axis or infiltration segment too long more than 2.5 cm that the remaining segment will not coapts after resection.

  3. Metastatic disease

Primary outcomes:
measure: Rate of postoperative anastomosis leakage
timeFrame: One month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Cheng Y, Briarava M, Lai M, Wang X, Tu B, Cheng N, Gong J, Yuan Y, Pilati P, Mocellin S. Pancreaticojejunostomy versus pancreaticogastrostomy reconstruction for the prevention of postoperative pancreatic fistula following pancreaticoduodenectomy. Cochrane Database Syst Rev. 2017 Sep 12;9(9):CD012257. doi: 10.1002/14651858.CD012257.pub2.
citation: Que W, Fang H, Yan B, Li J, Guo W, Zhai W, Zhang S. Pancreaticogastrostomy versus pancreaticojejunostomy after pancreaticoduodenectomy: a meta-analysis of randomized controlled trials. Am J Surg. 2015 Jun;209(6):1074-82. doi: 10.1016/j.amjsurg.2014.07.019. Epub 2015 Jan 22.