Poon 2007.
| Methods | Randomized clinical trial (registered in a clinical trial website of Hong Kong www.hkclinicaltrials.com, no. HKCTR‐12)
Allocation sequence: random numbers
Allocation concealment: sealed envelopes. We considered both allocation sequence generation and allocation concealment to be adequate.
Blinding: not mentioned Follow‐up: adequate. Lost to follow up: n = 0 Dropouts: n = 0 Informed consent: reported Intention‐to‐treat analysis: used, but no detailed information Sample size calculation: performed |
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| Participants | Country: Hong Kong, China Single center: Department of Surgery, The University of Hong Kong, Queen Mary Hospital, between June 2000 and October 2006. No. randomized: 120 Age: 67 participants ≦ 65 years, 53 participants ≩ 65 years Gender: Male/Female: 72/48 Inclusion criteria: Underwent elective PD for benign or malignant pathologies of pancreas or periampullary region. Exclusion criteria: Underwent emergency PD for trauma. Ongoing acute pancreatitis at the time of operation. Recruited before surgery but were found to have unresectable disease after laparoscopy or laparotomy Definition of pancreatic fistula: amylase‐rich fluid (amylase concentration 3 times the upper limit of normal serum amylase level) collected from the peripancreatic drains after postoperative day 3 with a drainage volume of 10 mL per day Conflicts of interest: none |
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| Interventions | 120 participants who underwent PD with end‐to‐side pancreaticojejunal anastomosis were randomly assigned to 1 of 2 groups; duct‐to‐mucosa anastomosis was performed in all participants. Group 1: An external stent inserted across the PJ anastomosis into the pancreatic duct and brought out externally via the jejunal loop and abdominal wall (n = 60) Group 2: No stent in the PJ anastomosis (n = 60) | |
| Outcomes | The main outcome measures were: Pancreatic fistula or leakage Overall morbidity rate Hospital mortality rate Postoperative hospital stay No. of days to resume oral diet No. of days on total parenteral nutrition |
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| Notes | None | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Random numbers |
| Allocation concealment (selection bias) | Unclear risk | Sealed envelopes |
| Blinding (performance bias and detection bias) All outcomes | Unclear risk | Not mentioned |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Not mentioned |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not mentioned |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Detailed information, and dropouts: n = 0 |
| Selective reporting (reporting bias) | Low risk | According to the outcomes reported |
| Other bias | Unclear risk | Not mentioned |